ESHRE recommendations on Good Practice in the IVF laboratory

STUDY QUESTION: What is the current good practice in the IVF laboratory, based on the best available evidence in the literature, if available, and the expertise of the working group? SUMMARY ANSWER: The updated ESHRE Recommendations on Good Practice in the IVF laboratory provides recommendations on all activities in the IVF laboratory. WHAT IS KNOWN ALREADY?: A previous version of the Good Practice in the IVF laboratory guideline was published in 2015. The adoption of new techniques, the increasing complexity of procedures, and the introduction of a revised European legislation on the quality and safety of tissues and cells for human application pertinent to assisted reproduction together necessitated an update of the document. STUDY DESIGN, SIZE, DURATION: This document was developed according to a predefined methodology for ESHRE Good Practice recommendations. The working group reviewed the document of 2015, and based on this assessment, each group member updated one or more sections. Recommendations are supported by data from the literature, if available, and the expertise of the working group and were discussed until consensus was reached within the working group. PARTICIPANTS/MATERIALS, SETTING, METHODS: The working group included 10 members representing the ESHRE Special Interest Groups for Embryology, Safety and Quality, and Andrology, with different areas of expertise and representing different European countries and settings. Based on the available evidence and the expertise of the working group, recommendations were formulated. Following stakeholder review of the initial draft, the final version was approved by the working group and ultimately by the ESHRE Executive Committee. MAIN RESULTS AND THE ROLE OF CHANCE: The ESHRE IVF labs working group updated the recommendations on the general organization of an IVF laboratory (staffing and direction, quality management, and laboratory safety) and on the specific aspects of the procedures performed in IVF laboratories (identification of patients and traceability of their reproductive cells, consumables, handling of biological material, oocyte retrieval, sperm preparation, insemination of oocytes, scoring for fertilization, embryo culture and transfer, embryo biopsy for pre-implantation genetic testing, cryopreservation, and emergency procedures). The section on embryo culture and transfer was split up, the section on sperm preparation was expanded to cover all general andrological procedures, and a new section on biopsy procedure was introduced. LIMITATIONS, REASONS FOR CAUTION: Not all recommendations are supported by evidence. Other recommendations, published in legal documents, relevant and recent documents, manuals, and consensus papers, were taken into account when formulating the recommendations. WIDER IMPLICATIONS OF THE FINDINGS: The guideline group is confident that this document will be helpful to directors and managers involved in the management and organization of IVF laboratories and also to embryologists and laboratory technicians performing daily tasks. STUDY FUNDING/COMPETING INTEREST(S): The guideline was developed by ESHRE, which funded the guideline meetings, literature searches, and dissemination of the guideline. The guideline group members did not receive any financial incentives; all work was provided voluntarily. G.C. reports consulting fees from Gedeon Richter and Cooper Surgical and was part of the working group of the 'Guide to the quality and safety of tissues and cells for human application' of the European Directorate for the Quality of Medicines and Healthcare, on behalf of the Council of Europe. T.E. reports consulting fees from Nexpring Health and Esco Medical and speaker's fees from Nexpring Health and Esco Medical. J.K.-B. reports research grants from Gates Foundation and NIHR, consulting fees from Bayer, speakers fees from Merck, IBSA, Ferring and Cooper Surgical, and travel support from Merck, IBSA, Ferring, and Cooper Surgical. I.S. reports speaker's fees from Vitrolife and Cooper Surgical. I.S. also declares being a member of ARCS Scientific Committee. The other authors disclosed no conflicts of interest. DISCLAIMER: This guideline represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a consensus between the relevant ESHRE stakeholders has been obtained. Adherence to these clinical practice guidelines does not guarantee a successful or specific outcome nor does it establish a standard of care. Clinical practice guidelines do not replace the need for application of clinical judgment to each individual presentation nor variations based on locality and facility type. ESHRE makes no warranty, express or implied, regarding the clinical practice guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose (full disclaimer available at www.eshre.eu/guidelines).